Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma.

Neuroblastoma Clinical Trial

Official title:

European Infant Neuroblastoma Study - Unresectable Tumors (MYCN Not Amplified)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00025597
• Other study ID #: CDR0000068977
• Secondary ID: EURO-INF-NB-STUD
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2001
• Last updated: September 16, 2013
• Start date: July 1999
• Est. completion date: February 2011

Study information

• Verified date: November 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.

Description:

OBJECTIVES:

• Determine the survival and morbidity of infants with newly diagnosed stage II or III unresectable neuroblastoma without MYCN amplification treated with vincristine and cyclophosphamide, etoposide and carboplatin, and cyclophosphamide, doxorubicin, and vincristine followed by surgery.

• Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients.

• Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to symptomatic spinal cord involvement (yes vs no).

Patients without evidence of symptomatic spinal cord compression receive vincristine IV on day 1 and cyclophosphamide IV on days 1-5. Treatment repeats every 14 days for 2 courses. Patients eligible for surgery undergo surgical resection and then are removed from the study.

Patients ineligible for surgery after 2 courses of initial chemotherapy, but with at least 25% response to initial chemotherapy, receive 2 additional courses of vincristine and cyclophosphamide. Patients eligible for surgery undergo surgical resection and then are removed from the study.

Patients ineligible for surgery after 2 additional courses of initial chemotherapy or with disease progression receive etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses. Patients eligible for surgery undergo surgical resection and then are removed from the study.

Patients who remain ineligible for surgery or with disease progression after etoposide and carboplatin receive cyclophosphamide IV over 1 hour on days 1-5, doxorubicin IV over 6 hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days for 2 courses. Patients then undergo surgical resection or biopsy.

Patients with symptomatic spinal cord compression receive initial treatment with etoposide and carboplatin as above. Patients with improved symptoms and resectable disease after initial chemotherapy undergo surgical resection or biopsy. Patients who remain ineligible for surgery or with no improvement in symptoms after initial chemotherapy receive cyclophosphamide, doxorubicin, and vincristine as above. Patients then undergo surgical resection or biopsy.

Patients are followed within 6 months and then annually for 5 years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 4 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed newly diagnosed stage II or III neuroblastoma or ganglioneuroblastoma

• Unresectable disease

• No MYCN amplification (i.e., fewer than 10 copies)

• No metastases to bone marrow

• No radiological bone lesions in skeleton

PATIENT CHARACTERISTICS:

Age:

• Under 12 months at diagnosis

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• No evidence of liver disease by ultrasound

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroblastoma

Intervention

Drug:
• carboplatin

• cyclophosphamide

• doxorubicin hydrochloride

• etoposide

• vincristine sulfate

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Austria	St. Anna Children's Hospital	Vienna
Belgium	Universitair Ziekenhuis Gent	Ghent
Denmark	Rigshospitalet	Copenhagen
France	Centre Hospitalier Regional de Purpan	Toulouse
Italy	Istituto Giannina Gaslini	Genoa
Norway	Rikshospitalet University Hospital	Oslo
Portugal	Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.	Lisboa
Spain	Hospital Universitario LA FE	Valencia
Sweden	Ostra Sjukhuset	Gothenburg
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
United Kingdom	Bristol Royal Hospital for Children	Bristol	England

Sponsors (1)

Lead Sponsor	Collaborator
European Infant Neuroblastoma Study Group - 1999

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Italy,  Norway,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (1)

Rubie H, De Bernardi B, Gerrard M, Canete A, Ladenstein R, Couturier J, Ambros P, Munzer C, Pearson AD, Garaventa A, Brock P, Castel V, Valteau-Couanet D, Holmes K, Di Cataldo A, Brichard B, Mosseri V, Marquez C, Plantaz D, Boni L, Michon J. Excellent out — View Citation